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FDA 510(k) Application Details - K182915
Device Classification Name
Tubes, Gastrointestinal (And Accessories)
More FDA Info for this Device
510(K) Number
K182915
Device Name
Tubes, Gastrointestinal (And Accessories)
Applicant
ENvizion Medical Ltd.
7 Haarad St
Tel Aviv 6971060 IL
Other 510(k) Applications for this Company
Contact
Doron Besser
Other 510(k) Applications for this Contact
Regulation Number
876.5980
More FDA Info for this Regulation Number
Classification Product Code
KNT
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
10/18/2018
Decision Date
02/13/2019
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
GU - Gastroenterology & Urology
Review Advisory Committee
GU - Gastroenterology & Urology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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